Establishing the variation of blood metrics within UK Biobank to inform cell therapy manufacturing processes.

Aim: Understanding blood component variation as a function of healthy population metrics is necessary to inform biomanufacturing process design. Methods: UK Biobank metrics were examined for variation in white blood cell count as an analog to potential manufacturing starting material input. Results: White blood cell count variation of four orders of magnitude (6.65 x 10(9) cells/l) was found. Variation increased with age, increased with weight up to 80 kg then decreased. Health state showed a greater absolute number of participants with elevated count. Female range was greater than male. Cell count/distributions were different between centers. Conclusion: This variation and range of process input signals a requirement for new strategies for manufacturing process design and control.